Kornimate/medical-research-clean huggingface dataset:
vascular effect of estrogens versus placebo evaluated by flow-mediated dilatation of brachial artery

Conditions: Unspecified Injury of Brachial Artery, Left Side, Initial Encounter

Summary: the aim of this study is to evaluate the vascular effects of estrogens on climacteric women measured by flow-mediated evaluation of the brachial artery using high resolution ultrasound and compare to placebo.

the interruption of the secretion of sex steroids that occurs after menopause, determines a change in vascular pattern at various levels. as a result, several side effects might appear and interfere with women's quality of life and health. the use of hormone replacement therapy has contributed to the improvement in these effects. it has been observed vascular beneficial effects of sex steroids in premenopausal women, and of hormone replacement therapy (hrt) in climacteric women, on the central retinal arteries. the objective of this study is to evaluate the effects of conjugated equine estrogen on flow-mediated dilation of the brachial artery.

Eligibility criteria:
inclusion criteria: * women without menstrual cycles within the last 12 months and fsh \> 30iu/l * healthy women * women that were not using drugs with potential vascular effect within the last 1 year * women that never used hormone replacement therapy exclusion criteria: * smoking * blood pressure \> 160/90 mm hg. * breast and or endometrial cancer * history of acute myocardial infarction * diabetes * vaginal bleeding of any origin * hepatic disease * thrombophlebitis or thromboembolic disorders

Keywords: hormone replacement therapy doppler velocimetry flow-mediated dilation menopause
inulin and the gut microbiota in healthy adults

Conditions: Gut Microbiota Dysbiosis and Nutrition

Summary: in this study the effects of a fibre dietary supplement on the gut microbiome in healthy adults will be investigated. for this purpose, a 14-day dietary supplementation with inulin or placebo (maltodextrin) will be carried out in healthy adults. the main objective of the study is to investigate inulin-induced changes in gut bacterial composition, bacterial gene expression, bacterial metabolite production and associated immune system changes.

healthy volunteers between the age of 18 and 60 will be recruited. in the first week of the study baseline blood and stool sampleswill be collected and nutritional information recorded. the participants will then take 15g of inulin or maltodextrin twice per day for 14 consequetive days. blood and stool samples will be collected daily during the inital phase of the intervention and again at the end of the intervention. from the stool samples bacterial nucleic acids will be isolated and used for metagenomic and transcriptomic analysis. the blood samples will be used to analyse for markers of barriere function and for analysis of immune cells.

Eligibility criteria:
inclusion criteria: * men and women in a 1:1 ratio * age 20 - 60 years * body mass index 18.5 - 34.9 kg/m2 exclusion criteria: * arterial hypertension, diabetes mellitus, known cardiovascular disease requiring treatment (e.g. coronary heart disease, stroke). * known end-organ damage to the brain, heart or kidneys * chronic kidney disease, need for dialysis * diseases or functional disorders that, in the opinion of the study doctor, preclude participation in the study * acute infections * malnutrition * antibiotics in the previous 4 weeks * regular consumption of probiotics or prebiotics * allergies * change in bodyweight of more than 2 kg in the previous 3 months * inability to uderstand the studie aims and study procedures * drug or alcohol abuse
delayed vs early enteral feeding after anterior sagittal anorectopexy

Conditions: Onset of Perineal Wound Infection

Summary: to study the effect of early vs delayed enteral feeding following asarp in females with congenital recto-vestibular fistula

congenital recto vestibular fistula represents the commonest type of anorectal malformation in females. the treatment of this anomaly is mainly approached either through anterior or posterior sagittal ano-rectoplasty approach. several perioperative factors may affect the outcome. one of major postoperative complications is the occurrence of wound infection. purpose: we aimed to study the effect of delayed vs early postoperative enteral feeding on the occurrence of postoperative wound infection and dehiscence. patients and methods: a prospective randomized trial included 55 infants with recto-vestibular fistula. all infants were managed by single stage anterior sagittal anorectoplasty at an age ≥ 3 months. patients were divided into two groups. group a included infants who started oral intake on the 5th postoperative day and group b included infants who started oral intake on the 2nd postoperative day. the primary outcome was the onset of perineal wound infection. group a infants were kept on peripheral parenteral nutrition during fasting period.

Eligibility criteria:
inclusion criteria: * all female infants with congenital rectoperineal fistula exclusion criteria: * patients with major anomalies, patients who have staged repair

Keywords: recto-vestibular fistula, early enteral feeding peripheral parenteral nutrition perineal wound infection
role of metabolomics in the diagnosis of endometriosis

Conditions: Endometriosis

Summary: endometriosis is one of the most common benign gynecological, affecting about 10% of premenopausal women. the pathophysiology of this disease is still not completely clear. despite its prevalence, there is no blood test available for the diagnosis of endometriosis and the average delay time to diagnosis is 9.4 years. metabolomics is a scientific discipline that studies changes in metabolites related to the pathophysiology of the disease. aim of the study is to identify an alteration in the expression of the metabolites in women with endometriosis


Eligibility criteria:
inclusion criteria: * women of childbearing age ; * written consent to laparoscopic surgery; * written consent to the study . exclusion criteria: * suspicion or diagnosis of malignant disease * inability or unwillingness to provide written consent

Keywords: endometriosis metabolomics
real-world experience - barostim™ advancing the level of clinical evidence (rebalance registry)

Conditions: Heart Failure

Summary: the purpose of this registry is to develop valid scientific evidence of the safety and benefit of barostim therapy in the commercial setting in patients with heart failure with reduced ejection fraction (hfref) that were recently implanted with the barostim system.

summary: the cvrx rebalance registry includes patients who have been implanted with the barostim system. up to 5,000 patients will be enrolled. data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry.

Eligibility criteria:
inclusion criteria: * patients can be included in the registry if they were implanted with a de novo barostim system. patients must sign an informed consent form after implantation with the barostim system in order to participate in the registry. indications: the barostim system is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are nyha class iii or class ii (who had a recent history of class iii), have a left ventricular ejection fraction ≤ 35%, a nt-probnp \< 1600 pg/ml and excluding patients indicated for cardiac resynchronization therapy (crt) according to aha/acc/esc guidelines. contraindications: * bilateral carotid bifurcations located above the level of the mandible * baroreflex failure or autonomic neuropathy * uncontrolled, symptomatic cardiac bradyarrhythmias * carotid atherosclerosis that is determined by ultrasound or angiographic evaluation greater than 50% * ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation * known allergy to silicone or titanium
indirect calorimetry guided energy provision in critically ill patients with obesity

Conditions: Critical Illness; Obesity

Summary: the direct trial is a prospective, multi-centre, two arm parallel feasibility pilot randomised controlled trial. the primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. the trial will recruit 60 mechanically ventilated patients from 4-6 icus in australia and new zealand.

indirect calorimetry is the current reference standard for measuring energy expenditure during critical illness, allowing for personalisation of energy delivery. use of indirect calorimetry may be important in mitigating under- and overfeeding and associated adverse outcomes. this may be particularly important in patients with obesity, where energy expenditure is difficult to estimate, and limited data is available on the optimal nutritional management of this subgroup. although access to indirect calorimetry is gradually improving, it remains an underutilised tool and skills required to complete and interpret measurements are limited which may hinder use and integration into practice. there is a resulting knowledge gap on the impact of indirect calorimetry on outcomes in comparison to standard care predictive equations. a definitive and pragmatic trial is needed to assess the impact of guiding energy delivery with indirect calorimetry on patient outcomes. importantly, confirming the feasibility of using indirect calorimetry to guide energy delivery is needed to define optimal measurement protocols prior to completion of a larger trial. the primary aim of the direct trial is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. the secondary aim is to inform a larger trial by collecting process, nutrition, functional, clinical and safety outcomes. the investigators will consider the main trial feasible to conduct if 2 of the following 3 feasibility criteria are achieved: (a) recruitment rate is ≥ 1 patient per calendar month; (b) between group separation of ≥20% in energy adequacy during icu admission is achieved in relation to measured energy expenditure and; (c) the number of indirect calorimetry measurements completed/planned ≥60% during icu admission.

Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) patients * body mass index ≥30 kg/m2 * between day 3 and 6 of index icu admission * receiving invasive mechanical ventilation * receiving enteral or parenteral nutrition exclusion criteria: * receiving extracorporeal membrane oxygenation support * major burns (≥20% total body surface area) * unable to perform indirect calorimetry within 24 hours of randomisation * known pregnancy * death is imminent * treating clinician believes the study is not in the best interest of the patient

Keywords: critical care nutrition indirect calorimetry
dose-dense induction/neoadjuvant chemotherapy in locally advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: dose-dense chemotherapy is a chemotherapy treatment plan in which drugs are given with less time between treatments than in standard chemotherapy. the two chemotherapy drugs used in this study, docetaxel and cisplatin, are approved for the treatment of lung cancer when given every 21 days. this study is exploring the response to chemotherapy when these drugs are given every 14 days. in addition, genetic tests will be performed on pre-treatment specimens to identify signatures that may predict chemotherapy sensitivity or resistance.

all patients will receive induction chemotherapy with cisplatin and docetaxel. pegfilgrastim will be administered approximately 24 hours following the end of the day 1 chemotherapy infusion. cycles will be repeated every 2 weeks for 3 cycles. patients deemed to be resectable will undergo surgical resection followed by postoperative thoracic radiotherapy. patients deemed inoperable will additionally receive concurrent chemoradiotherapy. response, using radiographic and/or pathologic means, will identify two cohorts; responders and nonresponders.gene expression profiling will then be performed on pre-treatment specimens to identify signatures that predict for chemotherapy sensitivity or resistance. the target enrollment is 45 patients.

Eligibility criteria:
inclusion criteria: * patients with documented stage iii nsclc (iiia or iiib, without malignant pleural/pericardial effusion) are eligible for enrollment if they are considered appropriate for treatment with chemotherapy, radiation, or surgery; * iiia: t1-3 n2 m0, t3 n1 m0 * iiib: t4 n0-2 m0, t 1-4 n3 m0 * measurable or evaluable disease * previously untreated with chemotherapy or radiotherapy for lung cancer; * no brain metastases; * no prior xrt * performance status 0-2 * ≥18 years of age * informed consent * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelets ≥ 100 x 109/l * bilirubin ≤ 1.5 x upper limit of normal for the institution (uln) * sgot and sgpt ≤ 2.5 x uln for the institution * creatinine ≤ 1.6 mg/dl * hemoglobin ≥ 8.0 g/dl * peripheral neuropathy ≤ grade 1 exclusion criteria: * known sensitivity to e. coli derived products (e.g. filgrastim, humulin® insulin, l-asparaginase, humatrope® growth hormone, intron® a); * use of iv systemic antibiotics within 72 hours prior to chemotherapy; * known hiv infection * lithium or cytokines within 2 weeks prior of entry * additional concurrent investigational drugs * history of myelodysplastic syndrome * pregnant, nursing or having unprotected sex * not available for follow-up assessment * unable to comply with protocol procedures * illnesses that may compromise ability to give informed consent. * patients with a history of severe hypersensitivity reaction to taxotere® or other drugs formulated with polysorbate 80.

Keywords: dose-dense chemotherapy
almond consumption and glycemia

Conditions: Glucose Intolerance; Appetite Disorders; Glucose Metabolism Disorders (Including Diabetes Mellitus); Lipid Metabolism Disorder

Summary: this study will examine the effects of almonds consumed by adults with different body fat distributions on indices of carbohydrate and lipid metabolism.

there is considerable evidence supporting a causal role for truncal visceral fat depots in glucose dysregulation. individuals with large visceral fat depots have impaired suppression of free fatty acid release in response to insulin, elevated triglycerides and low concentrations of high density lipoprotein cholesterol. the high free fatty acid concentration may induce insulin resistance in the muscle and liver. there is more recent evidence that truncal subcutaneous fat depots are also problematic, though this literature is mixed. in contrast, gluteo-femoral fat depots have not been implicated in insulin resistance and dysregulation of carbohydrate metabolism. failure to account for differences in the contributions of these depots will add noise to measurements of dietary interventions to mitigate glucose dysregulation. previous studies have reported evidence indicating acute and chronic consumption of almonds improves glycemia. acute effects are important indicators of health benefit, but longer-term trials, ones permitting identification of the effects of a dietary intervention on hba1c, are more telling and clinically relevant. to more definitively establish the association between almond consumption and improved carbohydrate metabolism, we propose a six-month trial that contrasts the effects of almond consumption at optimal times of the day versus consumption of low nutrient dense snack foods on indices of carbohydrate metabolism, food intake and appetite in adults characterized by three distinct fat depots. participants will consume either almonds, or no nuts every day for 6 months. at baseline, participants will be weighed and undergo a dexa scan to determine body fat composition and will be assigned a group. blood will also be collected fasted and at stipulated times in response to a meal tolerance test to measure insulin, glucose, c-peptide, hba1c, lipid panel, gut peptides, and compliance to the diet. participants will be given links to complete appetite ratings and record food intake. participants will report to the lab every two weeks to be weighed, and get a resupply of almonds (if in the almond group). at the two-week mark on months 2 and 4, participants will be weighed, blood will be taken to assess compliance to the diet, and links will be given to complete appetite ratings and record food intake. at month 6, all measurements from baseline will be repeated.

Eligibility criteria:
inclusion criteria: * meeting one of the following body fat distribution criteria determined by dexa: 1. high visceral fat 2. high gluteo-femoral fat 3. high truncal subcutaneous fat * 18-60 years * no nut allergies exclusion criteria: * not meeting one of the body fat distribution criteria * allergic to nuts
rhodiola rosea for coronary microvascular disease

Conditions: Coronary Microvascular Disease

Summary: to investigate the effects of rhodiola rosea on coronary flow reserve and symptoms in patients with microvascular angina pectoris, and to evaluate adverse drug reactions. long-term clinical follow-up of 1 to 3 years was conducted to evaluate the effect of rhodiola rosea on long-term adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility criteria:
inclusion criteria: 1. repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks; 2. coronary normal or stenosis \< 20%; 3. ischemic depression in st segment during resting or exercise; 4. blood flow reserve (cfr) of the anterior descending coronary artery \< 2.0; 5. subjects or their guardians agreed to participate in this study. exclusion criteria: 1. previous myocardial infarction or pci or cabg treatment; 2. a history of heart failure or lvef \< 50%; 3. severe arrhythmia; 4. myocarditis, pericardium disease, valvular disease, or cardiomyopathy; 5. a history of stroke within half a year; 6. diabetes difficult to control; 7. refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm; 8. familial hypercholesterolemia; 9. takayasu arteritis, kawasaki disease or coronary artery malformation; 10. pregnant or nursing, or having the intention to give birth within one year; 11. hepatic or renal dysfunction; 12. other diseases which may cause serious risks to patients; 13. requiring warfarin anticoagulant therapy; taking potassium channel opener, ccb, acei drugs or traditional chinese medicines; 14. allergic to contrast agents or blood products; 15. patients who participated in clinical research of other drugs within 3 months before being selected.
trial of the use of antenatal corticosteroids in developing countries

Conditions: Preterm Birth

Summary: multi-country two-arm, parallel cluster randomized controlled trial to reduce neonatal mortality through increasing the rate of antenatal corticosteroid administration to eligible women.

one of the united nations millennium summit goals is to reduce the deaths of children \<5 years by two-thirds for 2015 (un, 2000). given that 38% of all under-five deaths worldwide occur in the first four weeks of life, the goal seems unattainable unless a significant fraction of the neonatal deaths are prevented (darmstadt et al., 2005). thus, the provision of health care during the perinatal period in developing countries is a top priority. preterm birth is a major cause of neonatal mortality, currently responsible for 28% of the deaths overall. as the contribution of preterm birth to neonatal deaths is well above 50% (macdorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. one of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth. the primary objective will be to evaluate whether a cluster-level multifaceted intervention, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, reduces neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six african, asian, and latin american countries.

Eligibility criteria:
this is an intent-to-treat design and thus all pregnancy outcomes of women who deliver in the study clusters and provide consent will be collected. cluster-level inclusion criteria include * at least 250 deliveries per year. * birth attendants within the health cluster will be consented to participate participant-level inclusion criteria include all pregnant women living in and delivering in the study cluster who: * are between 24 and 36 weeks ga; * present with signs of preterm labor, amniotic fluid leakage, hemorrhage, or hypertension; * provide consent for injection or present to a facility where it is standard of care. exclusion criteria: * there will not be any specific exclusion criteria for clusters or participants.

Keywords: antenatal corticosteroids, preterm birth, diffusion